Description
The Clinical Project Manager is responsible for leading several clinical project teams; developing comprehensive project plans; detailed timelines and milestone management; and all vendor management.Responsibilities:
- Responsible for overall project planning and execution for multiple clinical protocols
- Provides leadership in regularly scheduled study team meetings with both internal and external resources
- Manages Contract Research Organizations (CROs), vendors and contractors to ensure project requirements are met
- Ensures that protocol/project training (on-site and Investigator Meeting) for Investigators, Study Coordinators, Monitors and other key study personnel is conducted and appropriately documented as per Acorda SOP's
- Provides guidance to study team ensuring adequate management of the project Trial Master File
- Visits sites quarterly to monitor compliance with the protocol. Provides mentoring, and ensures adequate training and monitoring is in place
Requirements:
- B.S. degree in a scientific or health-related field (MS preferred)
- 6+ years of clinical research experience; 4+ years of field monitoring experience
- CRO/vendor management experience
- Experienced with medical device and/or IVD clinical trials
- Abilitity to travel 25% during peak periods